UV Spectrophotometric Estimation of Propranolol Hydrochloride and Rosuvastatin Calcium in Synthetic mixture using First Order Derivative Method
Dr. Ajay I. Patel, Shweta V. Gosai*, Dr. Amikumar J. Vyas, Dr. Nilesh K. Patel,
Dr. Ashok B. Patel
Pharmaceutical Quality Assurance Department, B. K. Mody Government Pharmacy College,
Rajkot, Gujarat, India.
*Corresponding Author E-mail: shwetagosai97@gmail.com
ABSTRACT:
To develop sensitive, accurate, precise and understandable UV spectrophotometric method for estimation of Propranolol hydrochloride and Rosuvastatin calcium in synthetic mixture. First order derivative simultaneous estimation was carried out by using UV visible double beam spectrophotometer. Propranolol hydrochloride and rosuvastatin calcium exhibited absorbance at working wavelength 239.43nm and 249.03nm respectively using distilled water as a solvent. Linearity was found in range of 1-24μg/ml for propranolol hydrochloride and rosuvastatin calcium. Accuracy was obtained between 95.40-103.40% that is 101.50% for Propranolol hydrochloride and 100.16% for Rosuvastatin calcium. Method was validated for its linearity, accuracy, precision, LOD, LOQ and robustness as per ICH guidelines. The aforementioned method was found specified for estimation of synthetic mixture without interference.
KEYWORDS: Propranolol hydrochloride, rosuvastatin calcium, First order derivative, UV spectrophotometric, ICH.
INTRODUCTION:
Figure 1: Structure of (A) propranolol hydrochloride (B) rosuvastatin calcium
Rosuvastatin calcium (ROSU Calcium) is (E)-(3R, 5S)-7-{4-(4-flourophenyl)-6-isopropyl-2-[methyl (sulphonylamino)]pyrimidin-5-yl}-3,5-dihydroxyhepten-6-oic acid calcium (2:1), is a synthetic lipid lowering agent which act on plasma lipids [3] [4]. It is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A, enzyme responsible for conversion of HMG-CoA to mevalonate, which was rate limiting step in cholesterol biosynthesis. Structure of rosuvastatin calcium is given in figure (B).
Combination of propranolol hydrochloride and rosuvastatin calcium is used in treatment of patient suffering from hypercholesterolemia with hypertension disease. Also used in diseases like dyslipidemia and hyper-triglyceridemia which encourages hypertension [5]. The literature review of propranolol hydrochloride and rosuvastatin calcium reveal that various analytical methods are available for the determination of individually and in combination. Various analytical methods like for propranolol hydrochloride, RP-HPLC [6], simultaneous equation methods and Q absorbance method [7], spectoflourimetric method [8], UV methods [9-13], RP-HPLC [14-17], IR and NIR [18-19], diffuse reflectance spectroscopy [20], light scattering and NMR [21], SERS [22] and for rosuvastatin calcium, UV methods [23-28], HPLC [29-33], RP-UPLC [34], stability indicating [35-38], LC-MS/MS [39-41], atomic absorption spectroscopy [42] methods are available. Also there are some UV spectrophoptometric [43-48], HPLC [49-51], HPTLC [52] methods available for combination with other drugs. However, first order derivative method was not reported so far. Thus, in present study it was decided to carryout first order derivative method and method was validated in compliance with ICH guideline (Q2 R1) [53]. First order derivative spectroscopy was more selective, accurate, precise and understandable method for the estimation.
MATERIAL AND METHOD:
Chemicals and Reagents:
Propranolol hydrochloride, rosuvastatin calcium and distilled water were provided by B. K. Mody Government Pharmacy College. UV visible spectrophotometer (UV-1800 Shimadzu) was used; data were processed using UV probe (version 2.6) software. Experiment was done at B.K. Mody Government Pharmacy College in 2019.
Instrumentation:
The proposed work was carried out on a Shimadzu UV-visible spectrophotometer (model UV-1800 series), which possesses a double beam double detector configuration with a 1cm quartz matched cell. All weighing was done on electronic balance (MAB 220 Wensar) (sensitivity - 0.1mg).
Selection of Solvents:
On the basis of solubility study, Distilled water was selected as the solvent for dissolving PROP HCl and ROSU Calcium.
Preparation of Standard stock solution:
Accurately weighed 10.0mg of PROP HCl and 10.0 mg of ROSU calcium was transferred into different 100.0ml volumetric flask separately. Drugs were dissolved in sufficient amount of distilled water and both the flasks were sonicated for 5 min. Volume of the solution was made up to 100.0ml for both the drugs to obtain concentration of 100.0µg/ml solution. Solutions were further diluted to obtain concentration of 8.0µg/ml.
Selection of wavelength:
Fix the dilutions of the working standard stock solution, 8.0µg/ml of propranolol HCl and rosuvastatin calcium were separately prepared and scanned in the UV range 200–400nm. The overlain zero-order absorption spectra of both drug were obtained. These absorbance spectra were converted to 1st order derivative spectra. After observing overlay first order derivative spectra with scaling factor 1 and Δλ 4 for propranolol HCl and rosuvastatin calcium, zero crossing points of drugs were selected. The first wavelength selected was 249.03nm (zero crossing point of propranolol hydrochloride), where rosuvastatin calcium showed considerable absorbance. The second wavelength selected was 239.43nm (zero crossing point of rosuvastatin calcium), where propranolol hydrochloride showed considerable absorbance.
Figure 2: Wavelength selection spectrum of (A) First derivative spectra overlay (B) Zero order spectra overlay
METHOD VALIDATION:
Linearity:
Linearity was performed by diluting Standard stock solution (100.0μg/ml) of both drugs by withdrawing 0.1 ml, 0.2ml, 0.4ml, 0.8ml, 1.2ml, 1.6ml, 2.0ml and 2.4ml into different 10ml volumetric flasks to obtain 1μg/ml, 2 μg/ml, 4μg/ml, 8μg/ml, 12μg/ml, 16μg/ml, 20μg/ml and 24μg/ml respectively, for both the drugs differently. Volume was made upto the mark with diluent.
Specificity:
Specificity was performed under 6 replicates at concentration 8μg/ml of propranolol HCl and rosuvastatin calcium with and without addition of excipients to check the interference of excipient.
Accuracy:
The accuracy of the method was carried out in triplicate at three different concentration levels 50, 100 and 150% (12, 16 and 20μg/ml) for propranolol HCl and rosuvastatin calcium respectively. The accuracy of method was evaluated by calculating percentage recovery.
Precision:
Repeatability was performed under 6 replicates at concentration of 8μg/ml of propranolol HCl and rosuvastatin calcium. Intra-day and inter-day variations of propranolol HCl and rosuvastatin calcium were performed in triplicate at three different concentration levels 50, 100, 150% (4, 8, and 12μg/ml). Results are expressed in the form of RSD.
LOD and LOQ:
The limit of detection (LOD) and limit of quantification (LOQ) were calculated experimentally. Calibration curve was repeated for five times and standard deviation (SD) of the intercepts was calculated. The LOD and LOQ of the drugs were derived by calculating the signal-to-noise (i.e. 3.3 for LOD and 10 for LOQ) ratio.
Robustness:
The robustness of method was established by introducing small change in experimental condition like wavelength. The changes made in wavelength ± 3nm (239.43, 236.43, 242.43nm for propranolol HCl and 249.03, 246.03, 252.03nm for rosuvastatin calcium) respectively. The robustness of the method was evaluated by calculating RSD.
Assay of synthetic mixture:
Synthetic mixture was prepared by mixing PROP HCl (8.0mg) and ROSU calcium (8.0mg) with SSG, MCC, magnesium stearate and talc. The amount of synthetic mixture equivalent to 8.0mg was diluted up to 100 ml. The solution was diluted with distilled water to make concentration 8μg/ml of both drugs.
RESULTS AND DISCUSSION:
Linearity: The calibration curve obtained for propranolol HCl and rosuvastatin calcium in the range of 1-24μg/ml. The correlation coefficient of propranolol HCl and rosuvastatin calcium was found to be 0.9994 and 0.9996 respectively.
Figure 3. Linearity spectra of (A) PROP HCl (B) ROSU calcium and (C) overlay spectra
Figure 4. Linearity graph of (A) PROP HCl and (B) ROSU Calcium
Specificity:
Excipient interference was not observed at the working wavelength of 239.43nm for propranolol HCl and 249.03 nm for rosuvastatin calcium, the method presented in this study is specific for drugs. % interference was found less than 0.5%. The result of specificity is given in table No.1.
Assay of synthetic mixture:
% drug content of synthetic mixture was found between 95-105%. The result of assay of mixture is given in table No. 2.
Accuracy:
Accuracy of the recommend method was evaluated by adding known amount of standard drug into the placebo at three contradictory levels in three replicates. Percentage recovery for propranolol HCl and rosuvastatin calcium was found in range of 95 to 105 and RSD was found to be NMT 2. The result of accuracy is given in table No. 3.
Precision:
Repeatability and intermediate precision express in term of RSD. Absorbance were determined and results found satisfactory for RSD < 2 for both intra-day and inter-day precision and including repeatability study. The result is given in table No. 4 and table No. 5.
Table 1: Specificity study for PROP HCl and ROSU Calcium
|
|
Conc (μg/ml) (n=6) |
Absorbance |
Concentration (μg/ml) |
Difference |
% Interference |
||
|
With excipient |
Without excipient |
With excipient |
Without excipient |
||||
|
PROP |
8 |
0.075 ± 0.003 |
8.25 ± 0.02 |
0.023±0.02 |
0.23 ± 0.3 |
||
|
ROSU |
8 |
0.010 ± 0.0 |
8.25 ± 0.0 |
0 |
0 |
||
Table 2: Assay study of synthetic mixture
|
Conc (μg/ml) (n = 3) |
Absorbance |
Conc. Found |
% drug content |
|||
|
PROP |
ROSU |
PROP |
ROSU |
PROP |
ROSU |
|
|
(8:8) |
0.074 |
0.010 |
8.13 |
8.25 |
101.70 |
103.12 |
Table 3. Accuracy study for PROP HCl and ROSU Calcium
|
% Recovery level |
Target conc (μg/ml) |
Spiked conc (μg/ml) |
% Mean recovery ± SD (n=3) |
|||
|
PROP HCl |
ROSU Ca |
PROP HCl |
ROSU Ca |
PROP HCl |
ROSU Ca |
|
|
50 |
8 |
8 |
4 |
4 |
94.41±1.09 |
101.15±1.51 |
|
100 |
8 |
8 |
8 |
8 |
101.50±0.81 |
100.16±1.51 |
|
150 |
8 |
8 |
12 |
12 |
98.25±0.32 |
98.19±1.51 |
Table 4. Intermediate study for PROP HCl and ROSU Calcium
|
Precision |
Intra day (n=3) |
Inter day (n=3) |
|||
|
Drug |
Level (%) |
Absorbance (mean ± SD) |
RSD |
Absorbance (mean ± SD) |
RSD |
|
Propranolol hydrochloride |
50 |
0.0386 ± 0.0005 |
1.493 |
0.0388 ± 0.0005 |
1.32 |
|
100 |
0.0743 ± 0.0005 |
0.672 |
0.0740 ± 0.0005 |
0.679 |
|
|
150 |
0.1093 ± 0.0013 |
1.219 |
0.1095 ± 0.0005 |
0.459 |
|
|
Rosuvastatin calcium |
50 |
0.005 ± 0.0 |
0 |
0.005 ± 0.0 |
0 |
|
100 |
0.010 ± 0.0 |
0 |
0.010 ± 0.0 |
0 |
|
|
150 |
0.015 ± 0.0 |
0 |
0.015 ± 0.0 |
0 |
|
Table 5: Repeatability study for PROP HCl and ROSU Calcium
|
Drug |
Concentration (μg/ml) (n=6) |
Mean concentration found (μg/ml) ± SD |
RSD |
|
Propranolol HCl |
8 |
8.19 ± 0.065 |
0.80 |
|
Rosuvastatin calcium |
8 |
8.25 ± 0.0 |
0 |
LOD and LOQ:
LOD and LOQ of propranolol HCl and rosuvastatin calcium were determined using average of slope and standard deviation of intercepts. LOD and LOQ were found to be 0.22μg/ml and 0.67μg/ml for propranolol HCl and 0μg/ml for rosuvastatin calcium respectively.
Robustness: Making a deliberate change in wavelength was take place and RSD of absorbance found to be less than 2%, specify that the method was robust.
Table 6: Robustness study for PROP HCl and ROSU Calcium
|
Conc (μg/mL) |
Absorbance at different wavelength (Propranolol hydrochloride) |
Absorbance at different wavelength (Rosuvastatin calcium) |
||||
|
239.43nm |
236.43nm |
242.43nm |
249.03nm |
246.03nm |
252.03nm |
|
|
8 |
0.074 |
0.090 |
0.030 |
0.010 |
0.012 |
0.009 |
|
0.074 |
0.090 |
0.030 |
0.010 |
0.012 |
0.009 |
|
|
0.073 |
0.089 |
0.030 |
0.010 |
0.012 |
0.009 |
|
|
Mean ± SD |
0.073 ± 0.0005 |
0.089 ± 0.0005 |
0.030 ± 0.0000 |
0.010 |
0.012 |
0.009 |
|
RSD |
0.783 |
0.643 |
0 |
0 |
0 |
0 |
CONCLUSION:
The proposed method for the spectrophotometric determination of propranolol hydrochloride and rosuvastatin calcium is facile, sensitive, reproducible with good accuracy and precision. As there is no interference of excipient at the working wavelength. It allows reliably the analysis of propranolol hydrochloride and rosuvastatin calcium in binary mixture.
ACKNOWLEDGEMENT:
The authors are acknowledging to management of B.K.Mody government Pharmacy College for their research guidance and financial support. The authors have also thankful to Faculty of quality assurance, B. K. Mody government pharmacy college, Rajkot for their help in this research.
CONFLICT OF INTEREST:
Author’s has declared that there is no conflict of interest.
REFERENCES:
1. Indian pharmacopoeia. Government of India. Vol-II. Ghaziabad: Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission. 2018; pp 3023.
2. Elison Brayfield et al; Editors. Martindale - The complete drug referenc, Pharmaceutical press UK. 2014; 358th ed: pp 1479.
3. Indian pharmacopoeia. Government of India. Vol-II. Ghaziabad: Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia Commission. 2018; pp 3141.
4. Elison Brayfield et al; Editors. Martindale - The complete drug referenc, Pharmaceutical press UK. 2014; 358th ed: pp 1488.
5. El-Abasawi NM, Attia KA, Abo-serie AA, Fattah AA. Simultaneous Determination of Rosuvastatin and Propranolol by HPLC in Pharmaceutical Dosage Form. Analytical Chemistry Letters. 2018; 8(1): 46-53.
6. El-Abasawi NM, Attia KA, Abo-serie AA, Fattah AA. Simultaneous Determination of Rosuvastatin and Propranolol by HPLC in Pharmaceutical Dosage Form. Analytical Chemistry Letters. 2018; 8(1): 46-53.
7. Shinde NG and Aloorkar NH. Development and validation of UV spectrophotometric method for simultaneous estimation of propranolol hydrochloride and rosuvastatin calcium in bulk drug and pharmaceutical dosage form. International Journal of Advances in Pharmaceutics. 2015; 4(5): 55-59.
8. El-Abasawi NM, Attia KA, Abo-serie AA, Fattah AA. Simultaneous determination of rosuvastatin and propranolol in their binary mixture by synchronous spectrofluorimetry. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2018; 46-53.
9. Bhandari A, Kumar B and Patel R. Spectrophotometric Estimation of Propranolol in Tablet Dosage Form. Asian journal of chemistry. 2008; 20(1): 802-804.
10. Martins SM, da Rosa FM, Souza F, Galan V, Müller V and Andreazza IF. Development and validation of analytical methodology for quantification of propranolol hydrochloride in a multiparticulate biphasic system by UV-vis spectrophotometry. Acta scientiarum chemistry. 2018; 40(1): 1-7.
11. El-Didamony AM. A sensitive spectrophotometric method for the determination of propranolol HCl based on oxidation bromination reactions. Drug testing and analysis. 2010; 2: 122-129.
12. Prashanth KN and Basavaiah K. Simple and Rapid Spectrophotometric Determination of Propranolol Hydrochloride as Base Form in Pharmaceutical Formulation through Charge Transfer Complexation. Chemical Sciences Journal. 2012; 1-12.
13. El-Emam AA, Belal FF, Moustafa MA, Ashry SM, El-Sherbiny DT and Hansen SH. Spectrophotometric determination of propranolol in formulation via oxidative coupling with 3-methyl benzothiazoline-2-one hydrazone. Il Farmaco. 2003; 58: 1179-1186.
14. Gupta VD. Quantitation of propranolol hydrochloride in pharmaceutical dosage form by HPLC. Drug development and industrial pharmacy. 1985; 11(11): 1931-1937.
15. Saleem K, Ali I, Umma K and Aboul-Enein H. Recent Developments in HPLC Analysis of b-Blockers in Biological Samples. Journal of Chromatographic Science. 2013; 51: 807–818.
16. Santoro MI, Cho HS and Kedor-Hackmann ER. Enantiomeric Separation and Quantitative Determination of Propranolol in Tablets by Chiral High-Performance Liquid Chromatography. Drug Development and Industrial Pharmacy. 2001; 27(7): 693–697.
17. Shaker HA, Qinna NA, Hroub HA, Omari MM and Badwan AA. RP-HPLC–UV Method for the Quantification of Propranolol in Rat's Serum and Krebs Buffer Using One-Step Protein Precipitation. Acta Chromatographica 2016.
18. Takka S. Propranolol hydrochloride anionic polymer binding interaction. Il Farmaco. 2003; 58: 1051-1056.
19. Marques Junior JM, Muller AL, Foletto EL, Costa AB, Bizzi CA and Muller EI. Determination of Propranolol Hydrochloride in Pharmaceutical Preparations Using Near Infrared Spectrometry with Fiber Optic Probe and Multivariate Calibration Methods. Journal of Analytical Methods in Chemistry. 2015.
20. Gotardo MA, Tognolli JO, Pezza HR and Pezza L. Detection of propranolol in pharmaceutical formulations by diffuse reflectance spectroscopy. Spectrochimica Acta Part A. 2007; 69: 1103–1109.
21. Ruso JM, Attwood D, Rey C, Taboada P, Mosquera V and Sarmiento F. Light Scattering and NMR Studies of the Self-Association of the Amphiphilic Molecule Propranolol Hydrochloride in Aqueous Electrolyte Solutions. J. Phys. Chem. 1999; 103: 7092-7096.
22. Subaihi A, Almanqur L, Muhamadali H, Almasoud N, Ellis DI, Trivedi DK, Hollywood KA, Xu Y and Goodacre R. Rapid, accurate, and quantitative detection of propranolol in multiple human biofluids via surface-enhanced Raman scattering. Analytical chemistry. 2016.
23. Singh H, Gupta RD, Gautam G. Determination of Rosuvastatin Calcium in bulk and Pharmaceutical dosage forms by using UV-Spectrophotometric method. Asian Journal of Pharmacy and Pharmacology. 2018; 4(1): 45-48.
24. Ramadani A, Mandil H and Alshelhawi N. Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations by oxidative using iodine and formation triiodide complex in acetonitrile. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 695): 579-585.
25. Ramadani A, Mandil H and Ali RF. Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations through ion pair complex formation using bromocresol. International Journal of Pharmacy and Pharmaceutical Sciences. 2015; 7911: 191-198.
26. Lima MF, Cassella RJ and Pacheco WF. Spectrophotometric determination of rosuvastatin in pharmaceutical formulations using quinalizarin. Brazilian Journal of Pharmaceutical Sciences. 2017; 53(3): 1-8.
27. Gupta A, Mishra P and Shah K. Simple UV Spectrophotometric Determination of Rosuvastatin Calcium in Pure Form and in Pharmaceutical Formulations. E-Journal of Chemistry. 2009; 6(1): 89-92.
28. Jain PS, Kale NK and Surana SJ. Quantitative estimation of Rosuvastatin in bulk and tablet dosage form by using area under curve method. Journal of pharmaceutical and bioscience. 2014; 4: 128-133.
29. Ângelo ML, Moreira FL, Ruela AM, Santos AL, Salgado HR and Araújo MB. Analytical Methods for the Determination of Rosuvastatin in Pharmaceutical Formulations and Biological Fluids: A Critical Review. Critical Reviews in Analytical Chemistry. 2018.
30. Bozhanov S and Maslarska V. Spectroscopic and high-performance liquid chromatography methods for determination of statins Review Articles. Pharmacia. 2016; 63: 35-48.
31. Caglar S and Toker S. Determination of Rosuvastatin at Picogram Level in Serum by Fluorimetric Derivatization with 9-Anthryldiazomethane using HPLC. Journal of Chromatographic Science. 2013; 53–58.
32. Pandya CB, Channabasavaraj KP, Chudasama JD and Mani TT. Development and validation of rp-hplc method for determination of rosuvastatin calcium in bulk and pharmaceutical dosage form. International Journal of Pharmaceutical Sciences Review and Research. 2010; 5(1): 82-86.
33. Hazra K, Chowdary A, Devgan M, Shukla R, Sarkar B and Suryawanshi A. Development and validation of rp-hplc method for estimation of rosuvastatin calcium solid dispersions tablets. Asian Journal of Pharmaceutical research. 2014; 4(3): 122-125.
34. Trivedi HK and Patel MC. Development and Validation of a Stability-Indicating RP-UPLC Method for Determination of Rosuvastatin and Related Substances in Pharmaceutical Dosage Form. Scientia Pharmaceutica. 2012; 393-406.
35. Reddy GR, Reddy PR and Jyothi PS. Development of a Stability-Indicating Stereo selective Method for Quantification of the Enantiomer in the Drug Substance and Pharmaceutical Dosage Form of Rosuvastatin Calcium by an Enhanced Approach. Scientia Pharmaceutica. 2014; 80: 279-296.
36. Raj HA, Rajput SJ, Dave JB and Patel CN. Development and validation of two chromatographic stability-indicating methods for determination of rosuvastatin in pure form and pharmaceutical preparation. International Journal of ChemTech Research. 2009; 1(3): 677-689.
37. Nadia MM, Badawey AM, Lamie NT and El-Aziz B. Selective chromatographic methods for the determination of rosuvastatin calcium in the presence of its acid degradation products. Journal of Liquid Chromatography and Related Technologies. 2014; 37(15): 2182–2196.
38. Litvi´ca M, Smica K, Vinkovi V and Filipan-Litvi M. A study of photodegradation of drug rosuvastatin calcium in solid state and solution under UV and visible light irradiation: The influence of certain dyes as efficient stabilizers. Journal of Photochemistry and Photobiology A: Chemistry. 2013; 525: 84– 92.
39. Shah A, Iqbal Z, Ahmad L, Nazir S, Watson DG, Khuda F, Khan A, Khan MI, Khan A and Fazli N. Determination of Rosuvastatin and Its Metabolite N-Desmethyl Rosuvastatin in Human Plasma by Liquid Chromatography–High Resolution Mass Spectrometry: Method Development, Validation and Application to Pharmacokinetic Study. Journal of Liquid Chromatography and Related Technologies. 2014.
40. Siddartha B and Babu S. Estimation and validation for determination of rosuvastatin in human plasma by lc/ms/ms method. Journal of Global Trends in Pharmaceutical Sciences. 2014; 5(3): 1979–1988.
41. Sultana N, Arayne MS and Ali NS. An Ultra-Sensitive LC Method for Simultaneous Determination of Rosuvastatin, Alprazolam and Diclofenac Sodium in API, Pharmaceutical Formulations and Human Serum by Programming the Detector. Analytical and Bioanalytical Techniques. 2012; 3(7).
42. Hassouna M, Abdel-Mageed AI and Salem HO. Indirect Oxygen Flask-Atomic Absorption Spectrometric Determination of Rosuvastatin Calcium. Biomedical journal of scientific and technical research. 2007; 1(2).
43. Daharwal S. Development and validation of UV spectrophotometric method for simultaneous estimation of Diazepam and Propranolol in bulk drug and its formulations. Asian Journal of Pharmaceutical Analysis. 2013; 3(1): 20-23.
44. Savaj B, Patidar AK and Raj H. Simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide in tablets formulation using spectrophotometric technique (Simultaneous equation method). Asian Journal of Pharmaceutical Analysis. 2014; 5(1): 36-40.
45. Savaj B, Patidar AK and Raj H. Simultaneous determination of Propranolol hydrochloride and Hydrochlorothiazide in tablets formulation using spectrophotometric technique (Simultaneous equation method). Asian Journal of Pharmaceutical Research. 2015; 5(1): 31-36.
46. Sireesha D, Lakshmi M and bakshi V. Development and validation of UV spectrophotometric method for the simultaneous estimation of Rosuvastatin and Ezetimibe in pharmaceutical dosage form. Asian Journal of Pharmaceutical Research. 2017; 7(3): 135-140.
47. Telrandhe R. Development and validation of UV spectrophotometry and RP-HPLC method for simultaneous determination of Rosuvastatin and Clopidogrel in Tablet dosage form. Asian Journal of Pharmaceutical Research. 2018; 8(1): 25-32.
48. Godavariya V, Prajapati PB, Bodiwala KB and Shah SA. Development and validation of two spectrophotometric methods for the simultaneous estimation of Rosuvastatin calcium and Aspirin in their combined dosage form. Asian Journal of Research in Chemistry. 2012; 5(2): 275-278.
49. Ladke A, Ingle A, Ranaware P and Damle M. Development and validation of stability indicating HPLC method for Rosuvastatin calcium and Fenofibrate in combination. Asian Journal of Research in Chemistry. 2012; 5(5): 606-610.
50. Moodbrindi PV, et al. A new simultaneous determination of Rosuvastatin calcium and its Lactone impurity by reverse phase HPLC method. Asian Journal of Pharmaceutical Research.2015; 5(4): 175-182.
51. Borole T, Dewani M, Gandhi S and Damle M. Simultaneous estimation of Rosuvastatin calcium and Fenofibrate in their combined tablet dosage form by HPLC method. Journal of Research in Chemistry. 2011; 4(10): 1557-1561.
52. Karkhanis V, Parikh V and Panchal R. Estimation of Rosuvastatin calcium in tablet dosage form by HPTLC method. Journal of Research in Chemistry. 2011; 4(8): 1206-1209.
53. ICH- Harmonized Tripartite Guideline, "Validation of analytical procedures: text and methodology Q2 (R1)." International Conference on Harmonization, IFPMA, Geneva, Switzerland, 2005.
Received on 12.06.2020 Modified on 07.07.2020
Accepted on 22.07.2020 ©Asian Pharma Press All Right Reserved
Asian J. Pharm. Ana. 2020; 10(4):189-194.
DOI: 10.5958/2231-5675.2020.00035.6